Remediation of Emotional Processing Deficits in MS: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Kessler Foundation
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Emotional Processing
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial. We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS as well
Detailed Description
This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS, as well. All participants will undergo a baseline evaluation assessing emotional processing abilities, cognitive functioning, and psychological functioning. Participants will then be randomized into two groups. During the treatment phase, the experimental group will receive the proposed intervention while the control group will receive a "placebo" treatment. Neuropsychological assessment will be repeated at the end of the intervention.
Investigators
Helen Genova
Research Scientist
Kessler Foundation
Eligibility Criteria
Inclusion Criteria
- •between the ages of 18-
- •diagnosis of Relapsing-Remitting Multiple Sclerosis.
- •can read and speak English fluently.
Exclusion Criteria
- •history of prior stroke or other neurological disease or injury.
- •history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder.
- •significant alcohol or drug abuse history.
Outcomes
Primary Outcomes
Emotional Processing
Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Change in scores on computerized tests of emotional processing
Secondary Outcomes
- Self report of Quality of Life(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8))
- Emotional Function(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8))